Effectiveness comparison of first-line CDK4/6 inhibitors in patients with hormone-positive HER2-negative advanced breast cancer according to tumor histology: a sub-analysis of the real-world, multicenter, Italian study PALMARES-2.
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Mazzoli Giacomo, Provenzano Leonardo, Dieci Maria Vittoria, Curigliano Giuseppe, Giuliano Mario, Botticelli Andrea, Lambertini Matteo, Rizzo Gianpiero, Pedersini Rebecca, Sirico Marianna, La Verde Nicla, Gennari Alessandra, Zambelli Alberto, Toss Angela, Piras Marta, Giordano Monica, Tagliaferri Barbara, Generali Daniele, Sartori Donata, Fotia Giuseppe, De Monte Matteo, Ligorio Francesca, Jacobs Flavia, Armani Giovanna, Zurlo Christian, Menichetti Alice, Griguolo Gaia, Faso Valeria, Schianca Ambra Carnevale, Munzone Elisabetta, Marra Antonio, Chiappe Edoardo, Scagnoli Simone, Pisegna Simona, Capasso Camilla, De Angelis Carmine, Arpino Grazia, Criscitiello Carmen, Guarneri Valentina, Pruneri Giancarlo, Mariani Luigi, PALMARES-2 study group, Vernieri Claudio
Аннотация
MATERIAL AND METHODS: In this sub-analysis of the multicenter, real-world PALMARES-2 study (NCT06805812), we assessed the predictive and prognostic value of lobular histology in HR+/HER2-aBC treated with first-line endocrine therapy (ET) plus CDK4/6i. The primary endpoint was real-world progression-free survival (rwPFS). Associations between histology and outcomes were adjusted for 15 covariates using multivariable Cox-regression and inverse probability of treatment weighting.
RESULTS: Among 1982 patients, 367 (18.5 %) had ILC and 1481 (74.7 %) non-special type (NST). Median follow-up was 29.8 and 31.2 months, respectively. ILC was associated with shorter rwPFS versus NST (adjusted hazard ratio [aHR]: 1.24, 95 %CI:1.04-1.47, P=0.017). Palbociclib efficacy was not affected by lobular histology (P for interaction = 0.553) while abemaciclib was less effective in ILC (P = 0.009). All three CDK4/6i achieved similar rwPFS in ILC (ribociclib vs palbociclib: aHR: 1.01, 95 %CI: 0.67-1.45, P = 0.949; abemaciclib vs palbociclib: aHR: 1.13, 95 %CI: 0.75-1.71, P = 0.551; abemaciclib vs ribociclib: aHR: 1.15, 95 %CI: 0.73-1.80, P = 0.549).
CONCLUSIONS: Tumor histology affects the real-world effectiveness of first line ET plus CDK4/6i. In ILC, all three CDK4/6i performed similarly; therefore, treatment selection should prioritize tolerability, manageability, drug-drug interactions, and patient preferences.